Many medical procedures employ medical grade cement in connection with the restoration and strengthening of bone structures. During such procedures, cement is typically dispensed to a bone to fill in voids or spaces in the bone or between medical devices or implants attached to or embedded within the bone. These dispensing devices may include systems as simple as syringes and as complex as electronically controlled valves.
Mixing bone cement, such as, e.g., High-Viscosity Radiopaque (HV-R) bone cement, requires integration of two materials, a monomer solution, for example, a liquid that is packaged in a glass vial and a powder. One difficulty with the cement monomer is that it generates toxic fumes that ideally need to be contained to prevent inhalation exposure by medical staff. Current cement mixing techniques involve breaking the monomer vial and pouring the fluid into the powder by hand, then sealing a mixing chamber. This results in ambient exposure to fumes from the monomer component. This disclosure describes improvements over these prior art technologies.
Accordingly, an injection device, system and method for mixing bone cement and prevent the escape of toxic fumes. In one embodiment, in accordance with the principles of the present disclosure, a device for mixing and containing fumes for a bone cement component is provided that comprises a vial holder configured for receiving and holding a vial therein; a holder chamber configured to receive and secure the vial holder therein when engaged with the vial holder, the vial holder and the holder chamber forming an enclosure for containing the vial; a vial-breaking device disposed in the holder chamber, the vial holder being configured to be advanced toward the vial-breaking device for breaking the vial and for releasing contents of the vial into the holder chamber; a filter disposed within the holder chamber; and an elastomeric seal positioned about the vial-breaking device having a first surface and an opposite second surface, the first surface positioned so as to contact a surface of the vial holder and the second surface positioned to contact a surface of the holder chamber whereby advancement of the vial holder deforms the elastomeric seal from a first diameter that is smaller than the diameter of the holder chamber to a second diameter that is larger than the first diameter and forms a seal against an inside wall of the holder chamber so as to seal the upper assembly for use when dispensing cement. That is, once the vial is broken, the fluid passes by the seal, and as the user continues to turn the knob the seal expands and seals the top chamber from the lower chamber. In one embodiment, the entire device is sealed as shipped and is only opened once the device is collapsed enough to cause the valve 48 to open. In addition, the seal also prevents fumes from escaping form the holder chamber.
The vial holder is configured to be advanced toward the vial-breaking device for breaking the vial and for releasing contents of the vial into the holder chamber. Once advanced against the elastomeric seal, the seal is compressed against a lower portion of the holder chamber to deform the seal and create a seal against the inner surface of the holder chamber. In one embodiment a filter is disposed within the holder chamber. In another embodiment, a port is in communication with the holder chamber through the filter such that when a vacuum is drawn at the port by a dispensing device, the contents of the vial can be drawn through the filter and into the dispensing device such that fumes are contained in the enclosure and the dispensing device.
In one embodiment, the system comprises a vial holder configured for receiving a vial therein and including a holding structure for maintaining the vial in the vial holder. The vial holder has an opening to expose a surface of a vial. The vial includes a monomer component for bone cement. A holder chamber is configured to receive and secure the vial holder. The vial holder is threadedly received in the holder chamber and is advanced in an advance direction by employing the threads or by being pushed in the advancing direction. The vial holder and the holder chamber form an enclosure for containing the vial. A vial-breaking device is disposed in the holder chamber. The vial holder is configured to be advanced toward the vial-breaking device for engaging the surface of the vial, breaking the vial and releasing contents, for example liquid monomer solutions, of the vial into the holder chamber past the nondeformed elastomeric seal. Once the vial holder is advanced further, the elastomeric seal is deformed to seal off the top chamber from the lower chamber and prevent fumes produced from the mixture of the monomer component with the powdered cement material from escaping from the device. In one embodiment, a filter is disposed within the holder chamber and a port in communication with the holder chamber. In this embodiment, mixed cement material can be drawn out of the holder chamber through the filter. In another embodiment, a one-way valve is disposed between the holder chamber and the port to prevent back flow into the holder chamber. A dispensing device is connectable to the port for drawing a vacuum at the port to draw the contents of the vial through the filter and into the dispensing device whereby fumes are contained in the enclosure and the dispensing device.
In one embodiment a system for containing fumes that are characteristic of the monomer itself as well as any fumes produced from the mixing of a bone cement component is provided. The system includes a vial holder configured for receiving a vial therein. A holding structure is provided for maintaining the vial in the vial holder. The vial holder has an opening to expose a surface of a vial. The vial includes a monomer component for bone cement. A holder chamber is configured to receive and secure the vial holder. The vial holder being threadedly received in the holder chamber and advanced in an advance direction by employing threads. In the alternative, a pressure fit advancement system can replace the threaded system. The vial holder and the holder chamber form an enclosure for containing the vial. A vial-breaking device is disposed in the holder chamber. The vial holder is configured to advance towards the vial-breaking device for engaging the surface of the vial, breaking the vial and releasing contents, for example, liquid monomer solutions, of the vial into the holder chamber. An elastomeric seal is positioned about the vial-breaking device. The elastomeric seal includes a first surface and an opposite second surface. The first surface of the elastomeric seal is positioned so as to contact a surface of the vial holder and the second surface of the elastomeric seal positioned to contact a surface of the holder chamber so that advancement of the vial holder compresses the elastomeric seal against the surface of the vial holder and changes the diameter of the elastomeric seal from a first diameter that is smaller than the diameter of the holder chamber to a second diameter that is larger than the first diameter. The deformed seal forms a seal against an inside wall of the holder chamber and prevents fumes from escaping from the holder chamber. A filter can be disposed within the holder chamber to retain the fumes within the chamber when the cement is being disposed. In one embodiment, a port is disposed in communication with the holder chamber through the filter. One-way valve is disposed between the holder chamber and a port to prevent back flow into the holder chamber. A dispensing device is connectable to the port for drawing a vacuum at the port so as to draw the contents of the vial through the filter and into the dispensing device such that the top chamber is isolated from the lower chamber and any fumes are contained in the enclosure.
In yet another embodiment, a method for mixing bone cement and containing fumes of the bone cement within the mixing device is provided. The method provides one of the devices or systems for containing fumes for a bone cement component of the present disclosure. The device or system includes a vial holder configured for receiving and holding a vial therein. A holder chamber configured to receive and secure the vial holder therein such that when engaged with the vial holder. The vial holder and the holder chamber form an enclosure for containing the vial. A vial-breaking device is disposed in the holder chamber. The vial holder is configured to advance toward the vial-breaking device for breaking the vial and for releasing contents of the vial into the holder chamber. An elastomeric seal and a filter are disposed within the holder chamber. A port is in communication with the holder chamber through the filter. Providing a vial containing a monomer component to react with the bone cement powder in the vial holder. Advancing the vial holder in the holder chamber breaks the vial against the vial-breaking device and releases the monomer to mix with the powder cement material. Further advancing the vial holder contacts the elastomeric seal and deforms the seal to form a seal against the inside surface of the holder chamber. This seal not only prevents the escape of toxic fumes from the enclosure and separates the top chamber from the lower chamber but also aids in compressing cement where a high-pressure seal is required for mixing and delivery of the viscous resulting cement material. Drawing a vacuum at the port by a dispensing device, for example, a syringe draws the contents of the holder chamber through the filter and into the dispensing device such that fumes are contained in the enclosure and the dispensing device.
Like reference numerals indicate similar parts throughout the figures.